Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer
1 other identifier
interventional
62
1 country
1
Brief Summary
This randomized trial is designed to identify the safety and efficacy of single port laparoscopic surgery in colon cancer compared with conventional laparoscopic surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 15, 2010
CompletedFirst Posted
Study publicly available on registry
September 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedFebruary 3, 2016
February 1, 2016
10 months
September 15, 2010
February 2, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
rate of intraoperative complication
1 day
rate of 30 day morbidity and mortality
1 month
Secondary Outcomes (5)
operation time
1 day
degree of postoperative pain
5 days
amount of postoperative analgesics usage
5 days
postoperative functional recovery
7 days
Duration of postoperative hospital stay
7 days
Study Arms (2)
Single port laparoscopic surgery
EXPERIMENTALConventional laparoscopic surgery
ACTIVE COMPARATORInterventions
laparoscopic surgery in which all the instrument was entered into the abdominal cavity through the single port in the umbilicus
laparoscopic surgery in which each of the instrument were entered into the abdominal cavity through the multiple port in multiple quadrants of abdomen
Eligibility Criteria
You may qualify if:
- pathologic proven colon cancer
You may not qualify if:
- Tumor located in distal transverse colon, splenic flexure, and descending colon
- distant metastasis
- acute obstruction and/or perforation
- associated with FAP or HNPCC
- synchronous malignancy
- ASA score 3 or 4
- pregnancy
- no consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyung Hee University School of Medicine, Neo Medical Center
Seoul, 134-727, South Korea
Related Publications (1)
Kang BM, Park SJ, Lee KY, Lee SH. Single-Port Laparoscopic Surgery Can Be Performed Safely and Appropriately for Colon Cancer: Short-Term Results of a Pilot Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2017 May;27(5):501-509. doi: 10.1089/lap.2016.0467. Epub 2017 Jan 6.
PMID: 28061037DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suk Hwan Lee, MD. PhD
Kyung Hee University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
September 15, 2010
First Posted
September 17, 2010
Study Start
June 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2012
Last Updated
February 3, 2016
Record last verified: 2016-02